FDA product code EHQ: Cusp, Preformed
EHQ is the FDA product code for cusp, preformed. It is a Class I device, regulated under 21 CFR 872.3360 and reviewed by the Dental panel. Devices under EHQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Cusp, Preformed |
| Device class | Class I |
| Regulation | 21 CFR 872.3360 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Recalls for EHQ devices
openFDA lists no recalls for product code EHQ.
Frequently asked questions
What is FDA product code EHQ?
EHQ is the FDA product code for cusp, preformed. It is a Class I device, regulated under 21 CFR 872.3360 and reviewed by the Dental panel.
What device class is EHQ?
Class I, regulation 21 CFR 872.3360. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code EHQ
- Run a recall and safety report across every EHQ manufacturer
- Watch product code EHQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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